Interim Data Analyses & Monitoring: Interim analyses for the evaluation of safety and efficacy will be conducted based on the recommendations of the Data Safety & Monitoring Board. The DSMC will serve to monitor for safety and efficacy. DSMB reports produced by Dr. Hulsey's team will include summary statistics: on mother recruitment (expected vs. actual), data form quality (completion and timeliness of forms); tracking of data editing; demographics of the randomized mothers; aggregate safety; aggregate efficacy; and related information. The DSMB also will monitor the trial from the standpoint of futility using the techniques of Lan and Wittes (119).